Journal of Occupational Medicine and Toxicology - Latest Comments

Principal author's response to the August 24, 2009 comments by the chief editors

James Heller — 2010-03-11T00:00:00Z

December 21, 2009

Editors-in-Chief, Journal of Occupational Medicine and Toxicology

Prof. Axel Fischer (Email: axel.fischer@charite.de)
Head, Allergy Research Division
Charité - School of Medicine, Free University and Humboldt University of Berlin
Berlin, Germany

Prof. David A. Groneberg (Email: david.groneberg@charite.de)
Professor and Director, Institute of Occupational Medicine
Charité - School of Medicine, Free University and Humboldt University of Berlin
Berlin, Germany

Dear Sirs:

Re: Science and industry: Conflict-of-interests in the field of toxicology

I am writing to respond to your letter of August 24, 2009 commenting on our manuscript, New views on the hypothesis of respiratory cancer risk from soluble nickel exposure; and reconsideration of this risk's historical sources in nickel refineries, published in the JOMT in September 2009. I have been away this fall and this is my first opportunity to address certain issues raised by your letter; and to correct one matter in our paper.

First, the correction: our paper was originally submitted on February 15, 2008, not March 5, 2009. It was peer reviewed, subsequently rewritten, and resubmitted in revised form on March 5, 2009. Following further minor revisions, it was accepted for publication in early June 2009, and published in September 2009. Please make the necessary revisions to the online paper on your journal’s website.

Second, it is truly unfortunate that you have chosen to write this letter. You and your publisher had the option at the time of the manuscript’s first submission in February 2008 to consider it for publication or to refuse its consideration when it raised questions of ‘integrity’ and ‘conflict of interest’ in your minds. However, to choose this third option of passing the paper and ourselves through an intensive, 18 month peer review, rewriting and revision process, before revealing your position to your readership and ourselves was underhanded and mean spirited behaviour, and likely violates codes of ethical conduct for peer reviewed scientific journalism.

Let me provide you with some background concerning the sponsorship issue. Since the current regulatory view is that all nickel compounds are carcinogenic (viz. IARC’s March 2009 Meeting on nickel), all new hypotheses testing their carcinogenicity must, perforce, be ‘negative’ hypotheses and, in your opinion therefore, ‘pro-industry’ hypotheses. In fact, our hypothesis arose from observations by environmental professionals in several nickel refineries that soluble nickel was unwarrantedly being characterized as carcinogenic; and that the supporting evidence for this opinion appeared to be concentrated in KNR’s epidemiology. As the previous administrative head of a government agency legislatively mandated to investigate industrial disease in Ontario, I had a great deal of experience in this field and was asked to investigate the basis for the opinion concerning soluble nickel’s carcinogenicity. At no time was my research on this issue interfered with or my views prescribed. On the contrary, I had access to industry professionals and data from around the world whenever I needed information unavailable through public channels, thanks to my co-author, Dr. Bruce R. Conard. Consequently, the scientific judgments reached in the submitted manuscript and its integrity rest entirely on my shoulders since I enjoyed a de facto arm’s length relationship with my sponsors. You couldn’t have known that in advance but this fact goes to the heart of my concerns about your reactionary and self-righteous behaviour.

It is reflexively assumed that industry sponsored research is inherently biased whereas research originating in academic institutions or public health agencies is inherently unbiased; and that the peer reviewed scientific literature provides a fact based body of knowledge upon which sound regulatory policy on chemicals can be constructed. Our ability to look beyond the published literature, however, has shown that its conclusions cannot always be taken at face value; and that regulators who rely unquestioningly on this source of information to build policy are liable to serious errors in scientific judgment.

This brings me to the freedom of speech issue. Your readers should appreciate that the publisher disallowed publication of fifteen files of additional data and information attached to our paper out of fear of infringing the intellectual property rights of their original owners. Yet we had already confirmed that this information was in the public domain and had been filed previously with regulators (e.g. environmental data) or with nickel researchers who eventually published their work [e.g. Thornhill (1986) was filed with Sir Richard Doll’s ICNCM Committee whose research appeared in ICNCM (1990)], or with other publicly accessible repositories. Those files were intended to support the conclusions in our paper and reconsideration of regulatory policy on nickel. Even worse, the publisher suggested rewording of a sentence in the concluding remarks of the abstract to our paper, again fearing liability with the strong implication that it would not be published had we refused the proposed change. This is censorship! So it is ironic indeed that you are taking pride in your liberal views on freedom of speech when we were forced to comply with your publisher’s censorial dictates.

The JOMT informs us that there have been 1,488 accesses to the article since its publication (not including PubMed Central or other archive sites), a level the journal rates as ‘Highly Accessed’ relative to age. In the 3+ months since its publication, however, the paper has not generated a single comment. This can only mean that, by tainting honestly conducted research with innuendoes of bias, your reckless letter has effectively discouraged debate and discussion by the interested readership. This result is antithetical to the aims of science, scholarship and journalistic integrity. I write, therefore, to request a retraction of your remarks and an apology. I also request that these responses be posted alongside this letter and our article on the JOMT website.

Yours sincerely,

James G. Heller, PhD, DECH

c.c. Bruce R. Conard

Response to comments posted by Drs David A. Groneberg and Axel Fischer, JOMT Editors-in-Chief

Adriana Oller, Ph.D., DABT — 2010-03-11T00:00:00Z

In their comments, JOMT editors suggest that arguments made in the Heller et al. paper were not supported by solid scientific data, but they decided to publish this paper because "it can be regarded as a typical example of the approach of private companies towards the scientific discussion of compound toxicity and carcinogenicity," among other reasons. If the editors were of the view that the Heller et al. paper was not based on solid science, then it was their responsibility to reject it, as the whole purpose of the peer-review process is to ensure publication of sound science. Whether the author of a paper is an industry scientist or an academic scientist, different opinions can aid the scientific discourse as long as they are supported by solid, transparent data and subjected to the process of thorough peer review. No paper should be published unless this criterion is met.

As a toxicologist employed by the nickel industry (NiPERA), I believe that the nickel industry can and does support and publish scientifically rigorous studies. Although I disagree with the way that Heller et al. interpreted the nickel animal toxicology data and believe that the overall assertive tone of the paper goes beyond what the data warrants, this paper raises awareness about some key nickel refinery issues that could have (in a different format) contributed to the scientific debate on the carcinogenicity of soluble nickel. However, as it stands now, the JOMT missed an opportunity to assure that Heller’s paper meets accepted scientific standards. Publication of Heller’s paper in an appropriate format might have provided useful input to scientific debate in this area.

Adriana R. Oller, Ph.D, DABT
Toxicologist with NiPERA (Nickel Producers Environmental Research Association)

Science and industry: Conflict-of-interests in the field of toxicology

David A. Groneberg — 2009-08-24T00:00:00Z

In this report by Heller et al., two companies which are involved in the exploration, mining, and processing of nickel, sponsored a study that questions soluble nickel as a carcinogenic substance.
Although the editors agreed to publish this hypothesis, we feel that some clarifying words should be stated:

1) The editors-in-chief and the publisher questioned the integrity of the article on first sight. The first impression was to reject the article due to the magnitude of the conflict of interest. This conflict of interest arises from the nature of the sponsoring companies: The companies are Vale Inco and Falconbridge Ltd. Vale Inco is the second largest mining company in the world, with a market capitalization of more than US$ 125 billion and over 12,000 employees worldwide with net sales last year of over US$8 billion last year [1]. The second company Falconbridge Limited was a Canadian natural sources company that was absorbed in 2006.
2) After reviewing the article, the editors-in-chief decided to publish the article because: a) the conflict of interest is clearly stated: “Drs. Heller and Conard received financial support from Vale Inco Ltd. for the preparation of this paper. Dr. Heller also received financial support previously from Falconbridge Ltd. to conduct the underlying research in this paper. Mr. Thornhill has received no financial support.” b) the article reviews a large amount of studies and data – although partly onesided – that should be discussed by other non-biased scientists and c) it can be regarded as a typical example of the approach of private companies towards the scientific discussion of compound toxicity and carcinogenity.

The authors hypothesize that the true causes of historical lung cancer risk at certain nickel refineries may lie in other exposures, including insoluble nickel compounds, arsenic, sulphuric acid mists and smoking. This hypothesis is based by their failure to accurately identify the source(s) of observed lung cancer risk in one nickel refinery (KNR).
Freedom of speech is an important issue in science but also, the integrity of arguments represents a keystone when it comes to the discussion of toxic and carcinogenic effects. Ideally, scientists that are involved in research on nickel toxicity should now discuss the different points raised by Heller et al. in order to substantiate the knowledge on nickel toxicity.

David A. Groneberg, MD
Editor-in-Chief, Journal of Occupational Medicine and Toxicology
Professor of Medicine/Occupational Medicine

Axel Fischer, MD
Editor-in-Chief, Journal of Occupational Medicine and Toxicology
Professor of Medicine/Allergy

[1] http://www.inco.com/
[2] http://www.xstrata.com/

its a good report about music

Gul Ghuttai — 2009-01-27T00:00:00Z

HI<br><br> this is a very informative article..i learned a lot from it. I want to ask that is music also toxic to brain? are there new experiments done in this regard?

DENTAL ASSISTANTS (and the rest of the dental personnel) MUST BE GLAD

Servando Pérez-Domínguez — 2008-08-21T00:00:00Z

INDEED, dental assistants and the rest of the dental personnel, including dentists, must be glad because their professions (considered by the International Labour Organization as professions at risk for Chronic Mercury Poisoning), are, at last, really starting to be better studied, and, therefore, the dangers are timidly starting to be not fully hidden at the Faculties of Dentistry, Medicine, etc., or ‘underneath’ research projects, books or articles written by authors with various conflicts of interest, empty words, promises... We all know (the FDA had to recently recognised it publicly: www.mercuriados.org/es/pag254), that also those who have in their mouths dental amalgam fillings are at risk (but this was not the aim of this article).

Most probably, future generations will hardly understand why such dental material was still generally used in the 21st century, without at least considering the Precautionary Principle, and also knowing that, as Prof. Dr. Maths Berlin stated in the 2003 Report for the Swedish Dental Material Commission “Mercury in Dental-Filling Material--An Updated Risk Analysis in Environmental Medical Terms" — www.toxicteeth.org/Berlinbilaga.doc: “…fully adequate and less toxic alternatives are available” (p. 25).

All in all, our most sincere CONGRATULATIONS to the authors for conducting the research and for writing the article, and also our sincere CONGRATULATIONS to the Journal of Occupational Medicine and Toxicology for publishing the article, and, thus, allowing the readers to continue learning about the subtle (but relevant) health effects of such powerful heavy metal.

Santiago de Compostela, 20th August 2008

Servando.

www.mercuriados.org

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Prof. Servando Pérez-Domínguez

(President of the mercury poisoned patient organisation MERCURIADOS, and Medicine Student)

University of Santiago de Compostela, Spain

Email: servando.mercuriados@gmail.com

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"Real science is the one always open for constructive discussion" (José Ortega y Gasset).

Need for greater restraint in prescribing skeletal muscle relaxants specially to the elderly

Samuels hurstong — 2008-01-02T00:00:00Z

I would like to add to this article by pointing out the potential toxicity of skeletal muscle relaxant at theraputic doses, especially in the elderly population. I am interested in geriatric medicine, as guest faculty at UCSF we have seen a spate of confusion and agitation associated with the prescription of this class of drugs recently. Poly pharmacy in the elderly is something that needs to be looked at. This class of agents in particular can be associated with vast manifestations.

very topical and informative

Samuels hurstong — 2008-01-02T00:00:00Z

I was recently privy to the treatment of a patient with cyclobenzaprine overdose. This article details very well the protocols used in the management of such patients. There is very little data regards the management of such patients and this article certainly adds to the body of literature in this field. I must convey my regards to the author(s) for such a presentation.